Certificate of Free Sales in Dubai, Ras al-Khaimah, Ajman, Abu Dhabi, Al Ain, Fujairah- UAE

A document required in certain countries or for certain commodities (such as pharmaceuticals), medical devices- general, active implantable or in-vitro certifying that the specified imported goods are normally and freely sold in the exporting country’s open markets and are approved for export.

Many Ministries of Health and other regulators around the world require foreign manufacturers to provide a Certificate of Free Sale (CFS) showing that their products are approved for sale in Europe. In these markets, your CFS must be presented to authorities as part of your registration process. Ascent WORLD has obtained CFS documents for many clients seeking medical device registration in Asian, Middle Eastern and Latin American markets, and can procure a CFS on your behalf for your medical device.

A Free Sale Certificate is a certificate issued by a national regulatory authority of an exporting country based on national legislation confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country. A Free Sale Certificate is also known as a “Certificate for Export” or “Certificate to Foreign Governments”. It gives an assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country seeking to export a particular drug or medical device / product.

CFS

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An applicant may submit requests for certificates of free sale for the export purpose for:

– general medical device(s)

– active implantable medical device(s)

– in-vitro diagnostic medical device(s)

– a mixture of the above devices

A CFS is issued by a European Competent Authority upon request by an Authorized Representative on behalf of a medical device manufacturer. The CFS certifies that your medical device may be legally marketed in the European Union.

There are various types of certificates of free sale which are issued with reference to one of the above categories. Each certificate is issued in respect of a specified medical device product or products. The content will vary depending on whether the devices are CE marked or non-CE marked and whether the applicant is a manufacturer, authorised representative or legal manufacturer.

The MHRA (relevant EU Ministries’ Health & Regulatory Authority) can only issue a certificate of free sale: – where proof of manufacture is provided for the products concerned

– if the manufacturer is certified to manufacture products with a CE mark, where applicable

– if the manufacturer, authorised representative or legal manufacturer is located in EU

– if the device is non-CE marked for purposes of being sold outside of the EU,

the manufacturer is required to prove the CE marked equivalence of the medical device in question.

A CFS is issued on behalf of the EU Responsible Person.

The Responsible Person (RP) is a legal or natural person located in the EU responsible for ensuring that its products are safe and in full compliance with the Regulation. The RP is easily identifiable as its address is labelled on the pack.

According to the EU Regulations, each item/product must be assessed for safety by a duly qualified safety assessor before it is made available to the public. The RP is also responsible to ensure that the product has been manufactured under Good Manufacturing Practices. This requirement applies even if the product has been manufactured by another entity such as a contract manufacturer. Information relating to each product, its method of manufacture and its safety assessment, must be readily available to the Competent Authorities of the Member State where the RP is located.

A CFS issued centrally in the country of the RP, regardless of manufacturing location, is therefore the accepted practice.

A CFS can be requested on behalf of the RP by its sub-contractors or consultants.

Ascent WORLD has the resources and experience to secure your CFS

We source an appropriate Authorized Representative (EU Responsible Person) and the MHRA Certification for hundreds of medical device companies selling their products in Europe. In this capacity, we can request a CFS from the Competent Authority in any of the EU countries as efficiently and quickly as possible:

We have associate European Authorized Representative services since 2007
We have a presence in both Europe and many of the markets that require a CFS
Our established contacts in the EU Competent Authority ensures efficient CFS procurement

Following documents are required for issuing a Free Sale Certificate –

Application in the Form of Descriptive covering letter.
Copy of the valid manufacturing licences
List of products for which Free Sale Certificate is required
Copies of the product permission letters of the requested products for the issue of Free Sale Certificate
Relevant Application Fee for Free Sale Certificate containing products in one certificate Representation Fees.
Letter of the concerned authority-demanding certificate
Copy of the power of attorney/authorization letter

The above documents and fees mentioned are just indicative. The list is subject to change depending upon the regulatory authority requirement from time to time.